autosleepilot
The Long-term Impact of the Usage of New Generation Massage Chairs on Quality and Quantity of Sleep-in Individuals Suffering from Insomnia.
Sponsor study identifier
interventional
20
1 country
1
Study Start
March 4, 2024
Actual (reported)Primary Completion
December 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Modern technology is reshaping the massage industry, improving relaxation and well-being with pioneering devices. The automatic massage chairs stand as a testament to this evolution, integrating ergonomic design with advanced massage techniques to facilitate deep tissue relaxation, and sleep quality and enhance overall well-being. Aim: The aim of the current study is to assess the long-term impact of the new generations of massage chairs prior to bed-time in aspects related to sleep and quality of life in individuals with severe symptoms of insomnia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 4, 2024
Actual (reported)January 16, 2025
Actual (reported)January 23, 2025
Actual (reported)December 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sleep Efficiency
Total sleep time over Time spend in bed
At baseline, after each month and at the end of the 3 months period.
Insomnia Score
For the calculation of the Insomnia score, the Athens Insomnia Scale (AIS-8) will be used. The score ranges from 0 - 24 with a higher number implying worse insomnia symptoms.
At baseline, after each month and at the end of the 3 months period.
Sleep Quality Score
At baseline, after each month and at the end of the 3 months period.
Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-1: one month on, one month off, one month on. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).
Participants will follow a crossover design with a one-month interval period for three months in total. Participants will be randomly assigned into two equal-sized groups receiving the intervention (massage) following a distinct pattern: for the Group-2: one month off, one month on, one month off. During the "on" period, the massage chair will be located at the participant's house while during the "off" period, the massage chair will be removed from the participant's house (washout period).
The intervention is composed of a full-body relaxation massage offered by an automatic electric massage chair. The intervention will last for 3 months while the participant will change between massage and washout periods.
School of Physical Education, Sports and Dietetics, TEFAA
Trikala, Thessaly, GR42100, Greece
Xie J, Fu M, Liu T, Li S, Liu G, Wang J, Ji C, Zhang T. Clinical studies on the electric automatic massage therapy for recovery of acute sports fatigue. Technol Health Care. 2023;31(S1):185-197. doi: 10.3233/THC-236016.
Kim JW, Lim AR, Lee JY, Lee JY, Lee S, Choi YJ, Kim YH, Park KH. The clinical effect of an electric massage chair on chemotherapy-induced nausea and vomiting in cancer patients: randomized phase II cross-over trial. BMC Complement Med Ther. 2024 Apr 19;24(1):163. doi: 10.1186/s12906-024-04464-8.
Giorgos Sakkas, PhD
University of Thessaly
First Submitted
January 16, 2025
First Posted
January 23, 2025
Study Start
March 4, 2024
Actual (reported)Primary Completion
December 15, 2025
Estimated (date passed)Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
During this phase, participants will spend on month without any intervention (massage) accounting for a washout period.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Khairudin MN, Vallikkannu N, Gan F, Hamdan M, Tan PC. Electric massage chairs reduce labor pain in nulliparous patients: a randomized crossover trial. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101324. doi: 10.1016/j.ajogmf.2024.101324. Epub 2024 Mar 4.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 27, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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